FDA recall Z-1220-2026

Product

BEAR Implant. Model Number: 1000.

Reason for recall

Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.

Distribution

US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.

Key facts

Status

Ongoing

Initiation date

2025-12-31

Report date

2026-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2026